Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303

Matthew D. Galsky; Christopher J. Hoimes; Andrea Necchi; Neal Shore; J. Alfred Witjes; Gary Steinberg; Jens Bedke; Hiroyuki Nishiyama; Xiao Fang; Ritesh Kataria; Eric Sbar; Xieyang Jia; Arlene Siefker-Radtke

doi:10.2217/fon-2021-0273

Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303

Matthew D. Galsky, Christopher J. Hoimes, Andrea Necchi, Neal Shore, J. Alfred Witjes, Gary Steinberg, Jens Bedke, Hiroyuki Nishiyama, Xiao Fang, Ritesh Kataria, Eric Sbar, Xieyang Jia, Arlene Siefker-Radtke

Genitourinary Medical Oncology

Research output: Contribution to journal › Article › peer-review

20 Scopus citations

Abstract

Muscle-invasive bladder cancer (MIBC) is associated with high rates of recurrence and poor prognosis despite aggressive treatment. Neoadjuvant chemotherapy before radical cystectomy (RC) improves outcomes in cisplatin-eligible patients; however, the improvement in overall survival is modest. Standard of care for cisplatin-ineligible patients remains RC; more effective systemic therapies are needed. Recent Phase Ib/II studies suggest pembrolizumab monotherapy and combination therapy are effective neoadjuvant therapies for MIBC. The randomized Phase III KEYNOTE-866 and KEYNOTE-905/EV-303 studies are being conducted to evaluate efficacy and safety of perioperative pembrolizumab or placebo with chemotherapy in cisplatin-eligible patients with MIBC (KEYNOTE-866) and of pembrolizumab monotherapy versus pembrolizumab plus enfortumab vedotin versus RC plus pelvic lymph node dissection alone in cisplatin-ineligible patients with MIBC (KEYNOTE-905/EV-303). Clinical trial registration: NCT03924856 & NCT03924895 (ClinicalTrials.gov)</ext-link.

Original language	English (US)
Pages (from-to)	3137-3150
Number of pages	14
Journal	Future Oncology
Volume	17
Issue number	24
DOIs	https://doi.org/10.2217/fon-2021-0273
State	Published - Aug 2021

Keywords

Antibody-drug conjugate
Immunotherapy
Muscle-invasive bladder cancer
Nectin-4
Pembrolizumab
Perioperative
Programmed death 1
Radical cystectomy

ASJC Scopus subject areas

Oncology
Cancer Research

Access to Document

10.2217/fon-2021-0273

Cite this

Galsky, M. D., Hoimes, C. J., Necchi, A., Shore, N., Witjes, J. A., Steinberg, G., Bedke, J., Nishiyama, H., Fang, X., Kataria, R., Sbar, E., Jia, X., & Siefker-Radtke, A. (2021). Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncology, 17(24), 3137-3150. https://doi.org/10.2217/fon-2021-0273

@article{404230a4d0304a6fa45ffa997e46425b,

title = "Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303",

abstract = "Muscle-invasive bladder cancer (MIBC) is associated with high rates of recurrence and poor prognosis despite aggressive treatment. Neoadjuvant chemotherapy before radical cystectomy (RC) improves outcomes in cisplatin-eligible patients; however, the improvement in overall survival is modest. Standard of care for cisplatin-ineligible patients remains RC; more effective systemic therapies are needed. Recent Phase Ib/II studies suggest pembrolizumab monotherapy and combination therapy are effective neoadjuvant therapies for MIBC. The randomized Phase III KEYNOTE-866 and KEYNOTE-905/EV-303 studies are being conducted to evaluate efficacy and safety of perioperative pembrolizumab or placebo with chemotherapy in cisplatin-eligible patients with MIBC (KEYNOTE-866) and of pembrolizumab monotherapy versus pembrolizumab plus enfortumab vedotin versus RC plus pelvic lymph node dissection alone in cisplatin-ineligible patients with MIBC (KEYNOTE-905/EV-303). Clinical trial registration: NCT03924856 & NCT03924895 (ClinicalTrials.gov)",

keywords = "Antibody-drug conjugate, Immunotherapy, Muscle-invasive bladder cancer, Nectin-4, Pembrolizumab, Perioperative, Programmed death 1, Radical cystectomy",

author = "Galsky, {Matthew D.} and Hoimes, {Christopher J.} and Andrea Necchi and Neal Shore and Witjes, {J. Alfred} and Gary Steinberg and Jens Bedke and Hiroyuki Nishiyama and Xiao Fang and Ritesh Kataria and Eric Sbar and Xieyang Jia and Arlene Siefker-Radtke",

note = "Publisher Copyright: {\textcopyright} 2021 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.",

year = "2021",

month = aug,

doi = "10.2217/fon-2021-0273",

language = "English (US)",

volume = "17",

pages = "3137--3150",

journal = "Future Oncology",

issn = "1479-6694",

publisher = "Future Medicine Ltd.",

number = "24",

}

TY - JOUR

T1 - Perioperative pembrolizumab therapy in muscle-invasive bladder cancer

T2 - Phase III KEYNOTE-866 and KEYNOTE-905/EV-303

AU - Galsky, Matthew D.

AU - Hoimes, Christopher J.

AU - Necchi, Andrea

AU - Shore, Neal

AU - Witjes, J. Alfred

AU - Steinberg, Gary

AU - Bedke, Jens

AU - Nishiyama, Hiroyuki

AU - Fang, Xiao

AU - Kataria, Ritesh

AU - Sbar, Eric

AU - Jia, Xieyang

AU - Siefker-Radtke, Arlene

PY - 2021/8

Y1 - 2021/8

N2 - Muscle-invasive bladder cancer (MIBC) is associated with high rates of recurrence and poor prognosis despite aggressive treatment. Neoadjuvant chemotherapy before radical cystectomy (RC) improves outcomes in cisplatin-eligible patients; however, the improvement in overall survival is modest. Standard of care for cisplatin-ineligible patients remains RC; more effective systemic therapies are needed. Recent Phase Ib/II studies suggest pembrolizumab monotherapy and combination therapy are effective neoadjuvant therapies for MIBC. The randomized Phase III KEYNOTE-866 and KEYNOTE-905/EV-303 studies are being conducted to evaluate efficacy and safety of perioperative pembrolizumab or placebo with chemotherapy in cisplatin-eligible patients with MIBC (KEYNOTE-866) and of pembrolizumab monotherapy versus pembrolizumab plus enfortumab vedotin versus RC plus pelvic lymph node dissection alone in cisplatin-ineligible patients with MIBC (KEYNOTE-905/EV-303). Clinical trial registration: NCT03924856 & NCT03924895 (ClinicalTrials.gov)

AB - Muscle-invasive bladder cancer (MIBC) is associated with high rates of recurrence and poor prognosis despite aggressive treatment. Neoadjuvant chemotherapy before radical cystectomy (RC) improves outcomes in cisplatin-eligible patients; however, the improvement in overall survival is modest. Standard of care for cisplatin-ineligible patients remains RC; more effective systemic therapies are needed. Recent Phase Ib/II studies suggest pembrolizumab monotherapy and combination therapy are effective neoadjuvant therapies for MIBC. The randomized Phase III KEYNOTE-866 and KEYNOTE-905/EV-303 studies are being conducted to evaluate efficacy and safety of perioperative pembrolizumab or placebo with chemotherapy in cisplatin-eligible patients with MIBC (KEYNOTE-866) and of pembrolizumab monotherapy versus pembrolizumab plus enfortumab vedotin versus RC plus pelvic lymph node dissection alone in cisplatin-ineligible patients with MIBC (KEYNOTE-905/EV-303). Clinical trial registration: NCT03924856 & NCT03924895 (ClinicalTrials.gov)

KW - Antibody-drug conjugate

KW - Immunotherapy

KW - Muscle-invasive bladder cancer

KW - Nectin-4

KW - Pembrolizumab

KW - Perioperative

KW - Programmed death 1

KW - Radical cystectomy

UR - http://www.scopus.com/inward/record.url?scp=85111610718&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85111610718&partnerID=8YFLogxK

U2 - 10.2217/fon-2021-0273

DO - 10.2217/fon-2021-0273

M3 - Article

C2 - 34008425

AN - SCOPUS:85111610718

SN - 1479-6694

VL - 17

SP - 3137

EP - 3150

JO - Future Oncology

JF - Future Oncology

IS - 24

ER -

Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this